Section 61-03-02-04 - Distribution and control1. General. The consulting pharmacist shall establish written procedures for the safe and efficient distribution of pharmaceutical products; which shall be on hand for inspections.2. Responsibility of consulting pharmacist. The consulting pharmacist shall be responsible for the safe and efficient distribution of, control of, and accountability of medications by developing procedures subject to the approval of the pharmaceutical services committee of the long-term care facility, to include: a. Establishment of specifications for the storage, distribution, and procurement of medications and biologicals.b. Participation in those aspects of the long-term care patient evaluation program which relate to drug utilization and effectiveness.c. Providing information on a twenty-four-hour basis for assistance in emergency situations.d. Assuring all medication shall be stored in a locked area or locked cart.e. Review, evaluate, and make recommendations monthly regarding drug utilization to the pharmaceutical services committee.f. Minimum standards that all provider pharmacists must meet to include the following: (1) Expected delivery times for new orders and reorders.(2) Procedures to ensure accountability during delivery.(3) Methods to document receipt of medications by the facility.(4) Procedure to obtain emergency medications and for the provider pharmacist to receive orders.(5) Procedures used by the facility to reorder medications and for the provider pharmacist to receive reorders.(6) Expected scope of services and medications to be provided by the provider pharmacist. If the provider pharmacist cannot provide the complete scope of services and medications, the provider pharmacist shall designate alternative sources.g. Procedures that allow for use of or repackaging of medications received which are not in the packaging system used by the facility.h. Policy that is included as a part of the patient admissions packet that describes the responsibility of the patient or provider pharmacist to compensate a secondary pharmacist for medications or packaging services that the provider pharmacist chosen by the patient is either unwilling or unable to provide.3. Responsibility of provider pharmacist. All provider pharmacists shall meet the minimum standards established by the consulting pharmacist.4. Discontinued drugs.a. The consulting pharmacist shall develop and implement policies and procedures to ensure that all discontinued or outdated drugs or containers with worn, illegible or missing labels are destroyed or disposed of so as to render them unusable.b. Controlled drugs shall be destroyed at the nursing facility according to policies and procedures set by the consultant pharmacist. Destruction must render the medication nonretrievable. Destruction must be witnessed and documented on a log by a combination of at least two licensed staff members or pharmacists.c. Noncontrolled drugs may be destroyed at the institution according to policies and procedures set by the consultant pharmacist or returned to the provider pharmacy, for possible credit or destruction. 5. Practitioner's orders. A pharmacist shall review the medication order, or a copy thereof.a. Authorization. Any licensed practitioner authorized by law to prescribe drugs within the scope of the practitioner's license may prescribe for the practitioner's patient in a long-term facility.b. Abbreviations. Orders employing abbreviations or chemical symbols will be only those which are customarily used in the practice of medicine and pharmacy or those on a list of approved abbreviations developed by the pharmaceutical services committee of the facility.c. Requirements. Orders for drugs for use by patients of the facility shall, at a minimum, contain patient name, drug name and strength, directions for use, date of order, and name of prescriber. On the facility reorder form, include all of the above except for directions.d. Emergency medication order. In cases where an emergency medication order is written when pharmacy services are unavailable, the medication order shall be reviewed by the pharmacist as soon as reasonably possible.e. Verification. Verification of the accuracy of any medication dispensed and of any transcriptions made of that order shall be done by handwritten initials of the pharmacist so certifying.f. Duration. The prescribed medications should be for a specific time.6. An automated dispensing system is authorized for use in long-term care facilities to store controlled bulk drugs. a. Drugs in the automated dispensing system are not considered dispensed until taken out by authorized personnel at the long-term care facility, once released by the pharmacy pursuant to a prescription.b. Only single doses may be removed from the automated dispensing system at one time.c. The pharmacy must have a separate drug enforcement administration number for the automated dispensing system at each location.d. All records of dispensing must be kept at the central pharmacy.e. The automated dispensing system shall permit access to only one controlled substance at each authorized entry.f. Only retail pharmacies are authorized to use an automated dispensing system.g. Pharmacies cannot share an automated dispensing system at a long-term care facility.h. North Dakota controlled substance registration is required.7. Controlled drug accountability. The consulting pharmacist shall establish and implement effective procedures and assure that adequate records be maintained regarding use and accountability of controlled substances which meet federal and state laws and regulations, and which shall at least specify the following:e. Date and time of administration.f. Person administering the drug.8. Recall. The consulting pharmacist shall develop and implement a recall procedure that can readily be activated to assure the medical staff of the facility, the provider pharmacy, and the consulting pharmacist that all drugs included in the recall, located within the facility, are returned to the provider pharmacy for proper disposition.9. Records and reports. The consulting pharmacist shall supervise the maintenance of such records and reports as are required to ensure patient health, safety, and welfare and, at a minimum, the following:a. Pharmacy patient profiles and medication administration records.b. Reports of suspected adverse drug reactions.c. Inspections of drug storage areas.d. Controlled drug and accountability reports, including board of pharmacy destroyed medication forms for controlled and noncontrolled medications.e. Such other and further records and reports as may be required by law and this chapter. 10. Labeling. a. All stock drugs intended for use within the facility shall be in appropriate containers and adequately labeled as to identify at a minimum: brand name or generic name and manufacturer, and strength. An internal code which centrally references manufacturer and lot number can be utilized.b. Whenever any drugs are added to parenteral solutions, whether within or outside the direct and personal supervision of a pharmacist, such admixtures shall be labeled with a distinctive supplementary label indicating the name and amount of the drug added, date and time of addition, expiration date, administration time and infusion rate when applicable, and name or initials of person so adding. This excludes any single dose medication prepared and totally administered immediately. N.D. Admin Code 61-03-02-04
Effective August 1, 1983; amended effective October 1, 1999; December 1, 2003; October 1, 2007.Amended by Administrative Rules Supplement 374, October 2019, effective 10/1/2019.General Authority: NDCC 28-32-02, 43-15-10(12), 43-15-10(14)
Law Implemented: NDCC 28-32-02, 43-15-10(12), 43-15-10(14)